Need help with trying to get a non-conformance major to a minor. Or removed totally. I am HACCP certified and I have been planning top take the course but had several obstacles occur when trying to take it when offered. Small business and personal issues. I also did not realize the course was mandatory and that I needed to take the course. During my audit last year I was told it would be good to take it, not that I was required.

"The organization shall ensure that, at the time of delivery to its customer, the food supplied shall comply with the legislation that applies to the food and its production in the country of its origin and destination. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, trade weights and measures, packaging, product description, nutritional, allergen and additive labeling, and to relevant established Industry codes of practice

2.4.1 Food Legislation 2.4.1.1 Major There is no PCQI qualified individual at this small business site. (the deadline for this qualification was 9/18/17). The Food Safety Plan has not been updated to FSMA standards.
2.4.1.2 Compliant
2.4.1.3 Compliant
Section Summary: The Quality Manager keeps the plant informed of regulatory changes, through websites (FDA, SQF). The SQF Practitioner has not participated in a FSMA training."

I don't see how you get out of this. Your quoted part of the SQF code plainly says that you have to comply with legislative requirements.
Because you do not have a PCQI, regardless the reasons, you are not in compliance with legislative requirements (FSMA).

Do the training (and have someone else on staff do the training as well) and move on. :)

I am HACCP certified and I have been planning top take the course but had several obstacles occur when trying to take it when offered. Small business and personal issues. I also did not realize the course was mandatory and that I needed to take the course. During my audit last year I was told it would be good to take it, not that I was required.

You do not have to attend any specific training in order to be a PCQI, you can meet the requirements with relevant industry experience; so the idea that you haven't been to a training being the issue is incorrect. However, since you have not identified a PCQI and justified as to how they are qualified, the finding was correct, and the fact that you said you were not aware you needed to clarify this requirement does give some weight to the finding that you weren't keeping up to date with the regulations.

In short, I don't think you can fight off both, since you didn't have a compliant food safety plan for FSMA you definitely weren't following applicable laws. However you canbe a PCQI without having to attend any specific training, so your auditor is incorrect there.

1

QA Manager and food safety blogger in Oregon, USA.

Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

To expand on F3, I have been told over and over that formal training is not necessary, but the argument against it also hasn't been well defined. Since no one here has a college degree for food and we don't have any outside food safety experience, we figured we could not convince an auditor we were qualified. Here is the definition from the rule:

Preventive controls qualified individual means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.

Interests:We specialize in helping small to mid-sized food companies to develop & implement SQF Systems to achieve certification in a relatively short period of time. Our operational area includes the Unites States, Costa Rica, Panama and the Caribbean.

Posted 22 December 2017 - 09:15 PM

You have a challenge here and this major should be changed to a minor, appeal to the CB.

It will be the technically of the auditor incorrectly stating that you need to attend training - this is not a requirement.

You do, however have to show how you are the, what that is based on, etc.

I see no reason why you should not be able to knock this one down to a minor or eliminate it as the Auditor has made an error.

Interests:We specialize in helping small to mid-sized food companies to develop & implement SQF Systems to achieve certification in a relatively short period of time. Our operational area includes the Unites States, Costa Rica, Panama and the Caribbean.

Posted 23 December 2017 - 01:47 AM

Hi SQFC,

As I read the OP, I did not see any text stating that the auditor gave a major NC based on their understanding that passing a training course was necessary to be a PCQI ?

The problem seems to be that SQF auditors are unsure as to the required minimum capabilities for accepting that PCQI designated personnel are "qualified".

Sounds like the old argument of how much OJT = 1 certificate.

For me, the penultimate paragraph in OP and the thread title are both ambiguous ?

However you may ultimately still be proven correct in yr interpretation, ie there was an auditorial error.

Hi Charles,

First sentence from Michelle contains:

"Need help with trying to get a non-conformance major to a minor."

The major was here:

"2.4.1 Food Legislation 2.4.1.1 Major There is no PCQI qualified individual at this small business site. (the deadline for this qualification was 9/18/17). The Food Safety Plan has not been updated to FSMA standards."

Well, I miss-placed it, however where is the 9/18/17 requirement per SQF?

The question arises, what is the major for - the combo, the 9/18 thing or the food safety plan not being updated?

It might be grey, but I think it was an overstep by the Auditor or at the least not well clarified.

Actually I was mainly intending to comment regarding the "training" factor noted in Post 5. And as to the meaning of "qualified."

Regarding the validity of the assessed Major NC (assuming the auditor's findings are valid), FWIW here are the stated SQF "criteria" -

A minor non-conformity is an omission or deficiency in the SQF System that produces unsatisfactory conditions that if not addressed may lead to a risk to food safety but not likely to cause a system element breakdown.

A major non-conformity is an omission or deficiency in the SQF System producing unsatisfactory conditions that carry a food safety risk and are likely to result in a system element breakdown.

Above is reminiscent of the terminologies used in risk assessment / hazard analyses, ie subjective.

2.4.1 Food Legislation 2.4.1.1 Major There is no PCQI qualified individual at this small business site. (the deadline for this qualification was 9/18/17). The Food Safety Plan has not been updated to FSMA standards. Section Summary: The Quality Manager keeps the plant informed of regulatory changes, through websites (FDA, SQF). The SQF Practitioner has not participated in a FSMA training."

Based solely what you've posted here, you have a challenge. Had you previously identified your PCQI and the auditor decided that person is not qualified because of the lack of formal PCQI training? Did you present a food safety plan that complied with FSMA at the time of the audit? If so, that should have been evidence of PCQI qualification. You are correct, formal training is not required.

OTOH, if you had not done anything with FSMA, not ID'd a PCQI, did not demonstrate adequate knowledge, had not identified proper preventive controls, then I can see the major but the auditor did not do a very good job of stating the nonconformance. In either case, at least getting clarification from the CB is in order.

Well, I miss-placed it, however where is the 9/18/17 requirement per SQF?

The question arises, what is the major for - the combo, the 9/18 thing or the food safety plan not being updated?

It might be grey, but I think it was an overstep by the Auditor or at the least not well clarified.

The 9/18/2017 deadline is the FSMA compliance date for small business.

Interests:We specialize in helping small to mid-sized food companies to develop & implement SQF Systems to achieve certification in a relatively short period of time. Our operational area includes the Unites States, Costa Rica, Panama and the Caribbean.

Posted 26 December 2017 - 08:59 PM

Yes, I know the compliance date for FSMA, however I still go with clarity issue with the Auditor and the major should be a minor on challenge.

You do not have to attend any specific training in order to be a PCQI, you can meet the requirements with relevant industry experience; so the idea that you haven't been to a training being the issue is incorrect. However, since you have not identified a PCQI and justified as to how they are qualified, the finding was correct, and the fact that you said you were not aware you needed to clarify this requirement does give some weight to the finding that you weren't keeping up to date with the regulations.

Absolutely what I was about to say. I've been on PCQI training and it was painfully dull for UK Technical Professionals as we can't change our approach to HACCP without causing us massive problems in home and EU markets but it turns out that if you do HACCP well then there is a very good chance you will need to make very, very minor changes to your plan for compliance.

Why on earth though the FDA is showing zero sense on the training, I have no idea. I have well over 15 years experience in HACCP, L4 training etc yet they insist PCQI training must be delivered in full with every slide unchanged to people completely new to food safety and people have seen it, done it and got the t-shirt. A UK "conversion course" would be ideal, the training could then have been compressed from 3 days to less than 1.

I've been kicking this around a bit myself. After having read a PCQI certification book, I could tell that in almost every area SQF lvl 2 was more stringent then FSMA CFR (with a few exceptions). I am shocked more certified SQF practitioners, BRC managers, or HACCP managers aren't leveraging their certs and time spent in position as proof they are a PCQI. They all train you in "preventative controls."

Personally, in this instance, I would submit your most qualified individual (based on formal FS training and job experience) as your "PCQI" and formally put this change into your FSP, and then request you get it down to a minor based on you technically already employing a PCQI. Then to alleviate the minor, agree to get a formal PCQI training cert to close the gap.

I've been kicking this around a bit myself. After having read a PCQI certification book, I could tell that in almost every area SQF lvl 2 was more stringent then FSMA CFR (with a few exceptions). I am shocked more certified SQF practitioners, BRC managers, or HACCP managers aren't leveraging their certs and time spent in position as proof they are a PCQI. They all train you in "preventative controls."

Personally, in this instance, I would submit your most qualified individual (based on formal FS training and job experience) as your "PCQI" and formally put this change into your FSP, and then request you get it down to a minor based on you technically already employing a PCQI. Then to alleviate the minor, agree to get a formal PCQI training cert to close the gap.

Most of us are just doing the training anyway because 1: FDA inspectors are taking the exact same course (they were there during mine), and I want to know what training they receive on the subject. and 2: because the FDA inspectors went through the training and the regulations are "completely new" I don't want to spend my auditor goodwill arguing about why I didn't need to take the training because some other auditor thought it was absolutely necessary.

1

QA Manager and food safety blogger in Oregon, USA.

Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

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